1.2. Pediatrics

The FDA requires that all antidepressant drugs display a black box warning describing the potential for increased suicidal thinking and behavior when prescribed to children and adolescents with MDD and other psychiatric disorders. In short-term clinical trials, the suicide risk occurred twice as frequently with antidepressant-treated children/adolescents compared to those receiving placebo (4% vs. 2%, respectively) in the first few months of treatment. Pediatric patients prescribed antidepressant drugs should be closely monitored for changes in behavior.

Citalopram and paroxetine are not FDA-approved for use in pediatric patients as safety and effectiveness in this age group have not been well established. The olanzapine/fluoxetine combination is FDA-approved in pediatric patients.

Maximum pediatric recommended doses for SSRI antidepressants approved for use as monotherapy and combination therapy are summarized in Tables 3 and 4, respectively. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Tables 3 and 4. Dosages exceeding these recommendations will be reviewed.

Table 3: Recommended SSRI Antidepressant Drug Dosages for Pediatric Patients – Monotherapy 1-18
Drug Name Available Dosage Strengths Treatment Indication Literature Based Maximum Dosage FDA Approved Maximum Recommended Dosage
citalopram (Celexa®) 10 mg, 20 mg, 40 mg tablets; 30 mg capsule; 10 mg/ 5 mL oral solution  
  • Greater than or equal to 6 years of age:
    • 40 mg/ day
  • Not FDA approved for children & adolescents
escitalopram (Lexapro®, generics) 5 mg, 10 mg, 20 mg tablets; 5 mg/5 mL oral solution MDD
  • 6-11 years of age:
    • 20 mg/ day
  • Greater than or equal to 12 years of age:
    • 30 mg/day
  • 12 to 17 years of age:
    • 20 mg/day
fluoxetine (Prozac®, generics) 10 mg, 20 mg, 40 mg capsules; 10 mg, 20 mg, 60 mg tablets; 20 mg/5 mL solution MDD
  • Greater than or equal to 6 years of age: 60 mg/ day
  • 8 to 17 years of age: 20 mg/day
    OCD
  • Greater than or equal to 6 years of age: 60 mg/ day
  • 7 to 17 years of age:
    • lower weight children:
      • 30 mg/day
    • higher weight children:
      • 60 mg/day
fluoxetine (Prozac Pulvules®) 10 mg, 20 mg, 40 mg pulvules BD  
  • 10 to 17 years of age: 50 mg/ day^
    MDD
  • 8 to 18 years of age: 20 mg/day
  • 8 to 18 years: 20 mg/day
    OCD
  • 7 to 17 years of age: 60 mg/day
  • 7 to 17 years: 60 mg/day
fluvoxamine (generics) IR: 25 mg, 50 mg, 100 mg tablets OCD
  • Age 8-11 years:
    • 200 mg/day
  • Age 12-17 years:
    • 300 mg/day
  • 8-11 years of age:
    • 200 mg/day#
  • 12 to 17 years of age:
    • 300 mg/day#
Fluvoxamine controlled release (Luvox CR®, generics) CR: 100 mg, 150 mg OCD
  • Age 8-11 years:
    • 200 mg/day
  • Age 12-17 years:
    • 300 mg/day
  • 8-11 years of age:
    • 200 mg/day
  • 12 to 17 years of age:
    • 300 mg/day
sertraline (Zoloft®, generics) 25 mg, 50 mg, 100 mg tablets; 20 mg/mL oral concentrate OCD Age greater than or equal to 6 years: 200 mg/day 6 to 17 years of age: 200 mg/day

Legend:

  • BD = bipolar I disorder
  • IR = immediate-release
  • MDD = major depressive disorder
  • OCD = obsessive-compulsive disorder
  • # Fluvoxamine IR doses > 50 mg daily should be administered in divided doses, if the two doses are unequal the larger dose should be given at bedtime
  • ^ In combination with olanzapine
Table 4: Recommended SSRI Antidepressant Drug Dosages for Pediatric Patients – Combination Therapy1-2, 17-18
Treatment Indication Drug Name Available Dosage Strengths Literature Based Maximum Dosage FDA Approved Maximum Recommended Dosage
BD olanzapine/ fluoxetine (Symbyax®, generics) 3 mg/ 25 mg, 6 mg/ 25 mg, 12 mg/25 mg, 6 mg/ 50 mg, 12 mg/ 50 mg capsules Age 10-17 years: 12 mg olanzapine/50 mg fluoxetine once daily 10 to 17 years of age: 12 mg/50 mg per day

Legend:

  • BD = bipolar I disorder